Documentation Writer

Documentation Writer / Validation Responsible

Job Title : Documentation Writer

Number of Consultants: 1 (One)

Skill Area: Validation/Documentation

Main Technology: Microsoft Power Technologies

Location: Bangalore

Job Summary:

We are seeking an experienced Validation Responsible/Documentation Writer to join our team. The ideal candidate will have a strong background in IT solution implementation, particularly in Category 5 customized IT solutions, with expertise in validation, documentation, and GxP systems. This role involves ensuring compliance, managing risk assessments, investigating deviations, and handling change management, along with extensive documentation responsibilities.

Key Responsibilities:

Documentation:
• Write and review end-to-end documentation for IT solution implementations, specifically for Category 5 solutions.
• Create and approve validation deliverables, including Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV).

Validation & Compliance:
• Review and approve validation deliverables on behalf of NN QA.
• Conduct periodic reviews of IT solutions to ensure ongoing compliance.
• Understand and implement GxP and non-GxP system requirements.

Risk Management:
• Perform risk assessments during IT solution implementation and operation.
• Propose and implement Corrective and Preventive Actions (CAPA) for identified deviations.

Deviation & Change Management:
• Investigate deviations, identify root causes, and document CAPA proposals.
• Manage change requests and update related documentation accordingly.

Agile Implementation:
• Support IT solution implementations within Agile frameworks.
• Utilize validation tools like Azure DevOps (ADO) to track and manage project deliverables.

Mandatory Skills:
• Experience with Category 5 IT solution implementation.
• Expertise in creating documentation for IT implementations.
• Knowledge of GxP systems, risk assessment, and CAPA processes.
• Experience in managing change requests and periodic solution reviews.
• Hands-on experience with validation deliverables (IV, OV, PV).

Optional Skills (Good to Have):
• Familiarity with Microsoft PowerApps technologies.
• Experience in the pharmaceutical industry.
• Knowledge of validation tools such as ADO.
• Experience in Agile project frameworks.

Qualifications:
• Proven experience in validation and documentation roles.
• Strong knowledge of IT solution implementation and compliance processes.
• Ability to work independently and collaboratively with cross-functional teams.

Compensation: Competitive, based on experience.

How to Apply:

Please send your updated resume and a cover letter highlighting your relevant experience at visd@7n.com.

This role offers an opportunity to work on cutting-edge IT solutions in a dynamic and collaborative environment. If you meet the requirements and are ready to contribute to our team, we’d love to hear from you!